Ready Player Two: A randomised controlled pilot trial investigating the feasibility of using games to improve healthy lifestyle knowledge in youth (9-16 years) at risk for type two diabetes. (Preprint)

UNSTRUCTURED Objective: To determine the comparative use and knowledge effects of two prototype serious games for health on healthy lifestyle knowledge in youth aged 9-16 years at risk for type 2 diabetes (T2D). Methods: A three-arm parallel randomized controlled pilot trial was undertaken to assess use of the game, and the effect of the game on healthy lifestyle and T2D diabetes knowledge. Participants were allocated to ‘Diabetic Jumper’ (n=7), ‘Ari and Friends’ (n=8), or a control game (n=8). All participants completed healthy lifestyle and T2D knowledge questionnaires at baseline, immediately after game play, and four weeks after game play. Game attitudes and preferences were also assessed. The primary outcome was the use of the game, specifically, the number of minutes played over four weeks. Results: There were no statistical differences in healthy lifestyle knowledge or diabetes knowledge over time or across games. Only one participant accessed the game for an extended period, playing the game for a total of 33 min over 4 weeks. Conclusion: Two prototype serious were unsuccessful at sustaining long-term play outside a clinic environment. However, the potential for these games to be used as stimulus to engage young people with healthy lifestyle and diabetes knowledge in a clinic setting should be further explored. Suggested improvements for future studies are discussed. Trial Registration: Australia New Zealand Clinical Trials Registry, ACTRN12619000380190. Registered 11 March 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377123 Funding: The trial was funded by a Health Research Council of New Zealand Feasibility grant.

Download Full-text

Randomised controlled pilot trial comparing low dose and very low- dose microdrop administration of phenylephrine and cyclopentolate for retinopathy of prematurity eye examinations in neonates

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-318733 ◽

2020 ◽

pp. archdischild-2019-318733

Author(s):

Lisa Jean Kremer ◽

Roland Broadbent ◽

Natalie Medlicott ◽

Mary Jane Sime ◽

Frances McCaffrey ◽

...

Keyword(s):

New Zealand ◽

Adverse Effects ◽

Retinopathy Of Prematurity ◽

Neonatal Intensive Care ◽

Low Dose ◽

Pilot Trial ◽

Safety Data ◽

List Type ◽

Registration Number ◽

Randomised Controlled

AimsTo determine ifVery low dose mydriatic eye microdrop regimen sufficiently dilates the pupil (above 4.1 mm) compared with the currently used low dose mydriatic eye microdrop regimen.Cardiovascular, gastrointestinal and respiratory adverse effects occur following eye drop instillation.MethodsSeventeen premature infants were recruited into this prospective, randomised controlled pilot trial in January 2017 to November 2018. Data were collected from the single-centre Neonatal Intensive Care Unit, Dunedin Hospital, New Zealand. The inclusion criteria were birth weight less than 1500 g or gestational age less than 31 weeks, or any premature infant requiring red reflex testing. Infants were randomised to receive either phenylephrine 1% or 0.5% and cyclopentolate 0.2% or 0.1%, 1 microdrop in both eyes. Efficacy outcome measures were pupil size at retinopathy of prematurity eye examination (ROPEE) and ophthalmologist rating of ease of screen.ResultsAll participants had sufficient pupillary dilation for a successful ROPEE. Ophthalmologists rated the ROPEE as easy for 90% of all examinations. Pupil dilation measurements at the time of examination, mean±SD, 4.8±0.2 (95% CI 4.5 to 5.2) mm for treatment A and 5±0.2 (95%CI 4.6 to 5.4) mm for treatment B (p=0.61). There were no statistically significant differences between the groups for safety data.ConclusionsVery low dose microdrop administration of phenylephrine and cyclopentolate appears to be effective at sufficiently dilating the neonatal pupil for ROPEEs. Low dose and very low dose microdrop mydriatic regimens may also reduce the risk of unwanted adverse effects associated with these medicines.Trial registration numberAustralian New Zealand Clinical Trials Registry (reference ACTRN12616001266459p).

Download Full-text

A targeted promotional DVD fails to improve Māori and Pacific participation rates in the New Zealand bowel screening pilot: results from a pseudo-randomised controlled trial

BMC Public Health ◽

10.1186/s12889-019-7582-7 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Karen Bartholomew ◽

Lifeng Zhou ◽

Sue Crengle ◽

Elizabeth Buswell ◽

Anne Buckley ◽

...

Keyword(s):

New Zealand ◽

Randomised Controlled Trial ◽

Positive Impact ◽

Controlled Trial ◽

Trial Registration ◽

Reminder Letter ◽

Pacific People ◽

Screening Participation ◽

Test Kit ◽

Randomised Controlled

Abstract Background New Zealand’s Bowel Screening Pilot (BSP) used a mailed invitation to return a faecal immunochemical test. As a pilot it offered opportunities to test interventions for reducing ethnic inequities in colorectal cancer screening prior to nationwide programme introduction. Small media interventions (e.g. educational material and DVDs) have been used at both community and participant level to improve uptake. We tested whether a DVD originally produced to raise community awareness among the Māori population would have a positive impact on participation and reduce the proportion of incorrectly performed tests (spoiled kits) if mailed out with the usual reminder letter. Methods The study was a parallel groups pseudo-randomised controlled trial. Over 12 months, all Māori and Pacific ethnicity non-responders four weeks after being mailed the test kit were allocated on alternate weeks to be sent, or not, the DVD intervention with the usual reminder letter. The objective was to determine changes in participation and spoiled kit rates in each ethnic group, determined three months from the date the reminder letter was sent. Participants and those recording the outcomes (receipt of a spoiled or non-spoiled test kit) were blinded to group assignment. Results 2333 Māori and 2938 Pacific people participated (11 withdrew). Those who were sent the DVD (1029 Māori and 1359 Pacific) were less likely to participate in screening than those who were not (1304 Māori and 1579 Pacific). Screening participation was reduced by 12.3% (95% CI 9.1–15.5%) in Māori (13.6% versus 25.9%) and 8.3% (95% CI 5.8–10.8%) in Pacific (10.1% versus 18.4%). However, spoiled kit rates (first return) were significantly higher among those not sent the DVD (33.1% versus 12.4% in Māori and 42.1% versus 21.9% in Pacific). Conclusion The DVD sent with the reminder letter to BSP non-responders reduced screening participation to an extent that more than offset the lower rate of spoiled kits. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12612001259831. Registered 30 November 2013.

Download Full-text

Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00942-9 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Kate Leslie ◽

Matthew T. V. Chan ◽

Jai N. Darvall ◽

Anurika P. De Silva ◽

Sabine Braat ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Neuromuscular Blockade ◽

Controlled Trial ◽

Pilot Trial ◽

Pulmonary Complications ◽

Trial Registration ◽

Postoperative Pulmonary Complications ◽

Link Type ◽

Randomised Controlled ◽

Intrathoracic Surgery

Abstract Background Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. Methods Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). Results Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5–4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). Conclusions A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. Trial registration Prospectively registered at the Australian and New Zealand Clinical Trials Registry (ACTRN12620001313921) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true.

Download Full-text

Hearing aids to support cognitive functions of older adults at risk of dementia: the HearCog trial- clinical protocols

BMC Geriatrics ◽

10.1186/s12877-020-01912-1 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Dona M. P. Jayakody ◽

Osvaldo P. Almeida ◽

Andrew H. Ford ◽

Marcus D. Atlas ◽

Nicola T. Lautenschlager ◽

...

Keyword(s):

Older Adults ◽

At Risk ◽

Hearing Loss ◽

Cognitive Decline ◽

Hearing Aids ◽

Trial Registration ◽

Control Group ◽

Age Related ◽

Randomised Controlled ◽

The Impact

Abstract Background Globally, about 50 million people were living with dementia in 2015, with this number projected to triple by 2050. With no cure or effective treatment currently insight, it is vital that factors are identified which will help prevent or delay both age-related and pathological cognitive decline and dementia. Observational data have suggested that hearing loss is a potentially modifiable risk factor for dementia, but no conclusive evidence from randomised controlled trials is currently available. Methods The HearCog trial is a 24-month, randomised, controlled clinical trial aimed at determining whether a hearing loss intervention can delay or arrest the cognitive decline. We will randomise 180 older adults with hearing loss and mild cognitive impairment to a hearing aid or control group to determine if the fitting of hearing aids decreases the 12-month rate of cognitive decline compared with the control group. In addition, we will also determine if the expected clinical gains achieved after 12 months can be sustained over an additional 12 months and if losses experienced through the non-correction of hearing loss can be reversed with the fitting of hearing aids after 12 months. Discussion The trial will also explore the cost-effectiveness of the intervention compared to the control arm and the impact of hearing aids on anxiety, depression, physical health and quality of life. The results of this trial will clarify whether the systematic correction of hearing loss benefits cognition in older adults at risk of cognitive decline. We anticipate that our findings will have implications for clinical practice and health policy development. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR: 12618001278224), registered on 30.07.2018.

Download Full-text

Impact of a “vegetables first” approach to complementary feeding on later intake and liking of vegetables in infants: a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-021-05374-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jeanette P. Rapson ◽

Pamela R. von Hurst ◽

Marion M. Hetherington ◽

Cathryn A. Conlon

Keyword(s):

New Zealand ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Complementary Feeding ◽

Iron Status ◽

Controlled Trial ◽

Fruit And Vegetables ◽

Trial Registration ◽

Randomised Control Trial ◽

Randomised Controlled

Abstract Background Vegetables as first complementary foods for infants may programme taste preferences that lead to improved vegetable intake in children. Yet few studies have investigated the impact of a ”vegetables first” approach to complementary feeding, especially in New Zealand. The purpose of this randomised control trial is to investigate the effect of starting complementary feeding with vegetables only on infants’ later intake and liking of vegetables, compared to those starting with fruit and vegetables. Methods/design One-hundred and twenty mother-infant pairs living in Auckland, New Zealand, will be randomised to receive either vegetables only (intervention) or fruit and vegetables (control) for 28 days, starting from the first day of complementary feeding at around 4–6 months of age. Infants will be presented with a brassica (broccoli), followed by a green leafy vegetable (spinach) and sweet fruit (pear) at 9 months of age. The primary outcome measures of intake of each food will be assessed using a weighed food diary. Secondary outcome measures of overall intake, liking and wanting of vegetables will be assessed using a food frequency questionnaire, liking tool and video coding tool, respectively, at 9, 12, and 24 months of age. Infant growth and iron status will be assessed as part of health screening and monitoring at baseline, post intervention and 9 months of age. Other biological samples to be collected include infant stool samples, vitamin D (mother and infant), iron status (mother), and mothers’ diet. Discussion This randomised, controlled trial will be the first to our knowledge to investigate a “vegetables first” approach to complementary feeding on infants’ liking and intake of vegetables in New Zealand. Comparison against standard practice (fruit and vegetables as first foods) should complement other trials underway, such as the Baby’s First Bites and Nordic OTIS trial. Results may contribute to the evidence supporting complementary feeding guidelines in New Zealand and worldwide. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12619000737134. Registered on 16 May 2019.

Download Full-text

Deprescribing to reduce polypharmacy: study protocol for a randomised controlled trial assessing deprescribing of anticholinergic and sedative drugs in a cohort of frail older people living in the community

Trials ◽

10.1186/s13063-021-05711-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ulrich Bergler ◽

Nagham J. Ailabouni ◽

John W. Pickering ◽

Sarah N. Hilmer ◽

Dee Mangin ◽

...

Keyword(s):

New Zealand ◽

General Practitioner ◽

Older People ◽

Residential Care ◽

Controlled Trial ◽

Community Dwelling ◽

Trial Registration ◽

Home Support ◽

Sedative Drugs ◽

Randomised Controlled

Abstract Background Targeted deprescribing of anticholinergic and sedative medications in older people may improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community. Methods and analysis The standard protocol items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomized controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients. Study population Community-dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly. Intervention New Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend anticholinergic and sedative medications that could be deprescribed to the participant’s general practitioner. The total use of anticholinergic and sedative medications will be quantified using the Drug Burden Index (DBI). Outcomes The primary outcome will be the change in total DBI between baseline and 6-month follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalization, and death. Data collection points Data will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3). Ethics and dissemination Ethical approval has been obtained from the Human, Disability and Ethics Committee: ethical number (17CEN265). Trial registration ClinicalTrials.gov ACTRN12618000729224. Registered on May 2, 2018, with the Australian New Zealand Clinical Trials Registry

Download Full-text

Comparison of two invitation-based methods for human papillomavirus (HPV) self-sampling with usual care among un- and under-screened Māori, Pacific and Asian women: study protocol for a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening

BMC Cancer ◽

10.1186/s12885-019-6401-y ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Naomi Brewer ◽

Karen Bartholomew ◽

Anna Maxwell ◽

Jane Grant ◽

Helen Wihongi ◽

...

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

New Zealand ◽

Cancer Screening ◽

Usual Care ◽

Cervical Cancer Screening ◽

Trial Registration ◽

Asian Women ◽

Screening Participation ◽

Randomised Controlled

Abstract Background Māori, Pacific and Asian women in New Zealand have lower cervical-cancer screening rates than European women, and there are persistent inequities in cervical cancer outcomes for Māori and Pacific women. Innovative ways to address access barriers are required. New Zealand is transitioning to screening with human papillomavirus (HPV) DNA testing, which could allow women themselves, rather than a clinician, to take the sample. Internationally, self-sampling has been found to increase screening participation rates. The aim of this open-label community-based randomised controlled trial is to investigate whether self-sampling increases screening participation among un- and under-screened Māori, Pacific and Asian women in New Zealand. Methods/design We aim to invite at least 3550 un- or under-screened (≥5 years overdue) Māori, Pacific and Asian women (1050, 1250, 1250 respectively), aged 30–69 years, for screening. The three study arms are: usual care in which women are invited to attend a clinic for a standard clinician-collected cytology test; clinic-based self-sampling in which women are invited to take a self-sample at their usual general practice; and mail-out self-sampling in which women are mailed a kit and invited to take a self-sample at home. Women will be randomised 3:3:1 to the clinic and mail-out self-sampling groups, and usual care. There is also a nested sub-study in which non-responding women in all allocation groups, when they subsequently present to the clinic for other reasons, are offered clinic or home-kit self-sampling. The primary outcome will be the proportion of women who participate (by taking a self-sample or cytology test). Discussion This trial is the first to evaluate the effectiveness of mailed self-sampling in New Zealand and will be one of the first internationally to evaluate the effectiveness of opportunistic in-clinic invitations for self-sampling. The trial will provide robust evidence on the impact on participation proportions from different invitation approaches for HPV self-sampling in New Zealand un- and under-screened Māori, Pacific and Asian women. Trial registration ANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true; UTN: U1111–1189-0531.

Download Full-text

Deprescribing To Reduce Polypharmacy: Study Protocol For A Randomised Controlled Trial Assessing Deprescribing of Anticholinergic and Sedative Drugs In A Cohort of Frail Older People Living In The Community

10.21203/rs.3.rs-533256/v1 ◽

2021 ◽

Author(s):

Ulrich Bergler ◽

Nagham Ailabouni ◽

John W. Pickering ◽

Sarah Hilmer ◽

Dee Mangin ◽

...

Keyword(s):

New Zealand ◽

Randomised Controlled Trial ◽

Older People ◽

General Practitioners ◽

Residential Care ◽

Controlled Trial ◽

Community Dwelling ◽

Trial Registration ◽

Sedative Drugs ◽

Randomised Controlled

Abstract Background: Targeted deprescribing of anticholinergic and sedative medications in older people can improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community. Methods and analysis: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve three groups of older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomised controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients.Study population: Community dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly.Intervention: New Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend to general practitioners’ anticholinergic and sedative medications that could be deprescribed. Total use of anticholinergic and sedative medications will be quantified using the Drug Burden index (DBI).Outcomes: The primary outcome will be the change in total DBI between baseline and six-months follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalisation, and death.Data collection points: Data will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3).Ethics and dissemination: Ethics approval has been obtained from the Human, Disability and Ethics Committee. Ethical number (17CEN265).Trial registration: The trial was registered on 2 May 2018 with the Australian New Zealand Clinical Trials Registry: ACTRN12618000729224 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374924)

Download Full-text

Factors Influencing Men’s Experiences and Engagement with the Rugby Fans in Training—New Zealand Pilot Trial: A Healthy Lifestyle Intervention for Men

Healthcare ◽

10.3390/healthcare9121737 ◽

2021 ◽

Vol 9 (12) ◽

pp. 1737

Author(s):

Elaine Anne Hargreaves ◽

Samantha Marsh ◽

Ralph Maddison

Keyword(s):

New Zealand ◽

Lifestyle Intervention ◽

Thematic Analysis ◽

Healthy Lifestyle ◽

Pilot Trial ◽

Professional Sport ◽

Factors Influencing ◽

Health Promotion Programs ◽

Healthy Lifestyle Interventions ◽

Inductive Thematic Analysis

Health promotion programs designed specifically to support men to improve their lifestyle behaviours are required to improve men’s health. This study explored factors that influenced men’s experiences of, and engagement with, the Rugby Fans in Training—New Zealand pilot trial, a professional sport-based healthy lifestyle intervention for overweight men. Thirty-five men (mean age = 45, SD = 10 years) who completed the 12-week intervention participated in one of eight semi-structured focus groups. Using inductive thematic analysis, five themes represented the meanings in the data. First, a group of like-minded men all in the same boat recognised the importance of being in similar life situations and having similar reasons for joining the programme. Second, the men described the importance of the support and motivation provided by the team atmosphere created through the programme. Third, the motivational coach recognised the characteristics, skills and knowledge of the coach delivering the programme which created engagement with it. Fourth, the education sessions were valued for the knowledge gained and underpinning philosophies that guided them. Finally, the involvement of the rugby franchise influenced commitment to the programme and created initial interest. These results provide evidence for the key components that should be incorporated into the future development of and improvement to healthy lifestyle interventions for men.

Download Full-text

A Digital Human for Delivering a Remote Loneliness and Stress Intervention to At-Risk Younger and Older Adults During the COVID-19 Pandemic: A Randomised Pilot Trial (Preprint)

10.2196/preprints.31586 ◽

2021 ◽

Author(s):

Kate Loveys ◽

Mark Sagar ◽

Isabella Pickering ◽

Elizabeth Broadbent

Keyword(s):

Older Adults ◽

At Risk ◽

Nursing Home ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Pilot Trial ◽

Well Being ◽

Stress Intervention ◽

Randomised Controlled ◽

Digital Human

BACKGROUND Loneliness is a growing public health issue that has been exacerbated in vulnerable groups during the COVID-19 pandemic. Computer agents are capable of delivering psychological therapies through the internet, however, there is little research on their acceptability to date. OBJECTIVE The objectives of this study were to evaluate: (1) the feasibility and acceptability of a remote loneliness and stress intervention with digital human delivery to at-risk adults; and (2) the feasibility of the trial methods in preparation for a randomised controlled trial. METHODS A parallel, randomised pilot trial with a mixed design was conducted. Participants were adults aged 18–69 years with an underlying medical condition, or aged 70 years or older with a >24 MMSE score (i.e., at greater risk of developing severe COVID-19). Participants took part from their place of residence (20= independent living retirement village, 7= community dwelling, 3= nursing home). Participants were randomly allocated to the intervention or waitlist control group, who received the intervention one week later. The intervention involved completing cognitive behavioural (e.g., psychoeducation on stress awareness, deep breathing) and positive psychology exercises with a digital human facilitator on a website for at least 15-minutes per day over one week. The exercises used evidence-based strategies to improve loneliness, stress, and psychological well-being. Feasibility was evaluated using dropout rates and behavioural observation data. Acceptability was evaluated using behavioural engagement data, the Friendship Questionnaire (adapted), self-report items and qualitative questions. Psychological outcomes were measured to evaluate feasibility of trial methods and included loneliness (UCLA Loneliness Scale), stress (Perceived Stress Scale), COVID-19 distress, well-being (Flourishing Scale), and affect (Scale of Positive and Negative Experiences). RESULTS 30 participants (15 per group) were recruited. Participants were 22 older adults, and 8 younger adults with a health condition. 6 participants dropped out of the study. 24 participants’ data were analysed (12= intervention group; 12= waitlist group). The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently. Slow internet speed reduced intervention feasibility for some participants. Suggestions for improvement included: additional content, tailoring to the population, and changes for the digital human’s design. The intervention and trial methods were less feasible to nursing home residents who required caregiver assistance. CONCLUSIONS The digital human was a feasible and acceptable way of delivering a remote loneliness and stress intervention to at-risk adults during the COVID-19 pandemic. The intervention and trial methods were most feasible for people living independently. Support was found for further testing of digital humans to deliver remote psychological interventions. Findings will inform expansion of intervention content and the design of a randomised controlled trial to evaluate intervention effectiveness. CLINICALTRIAL Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000786998

Download Full-text